NCT06626698

Brief Summary

The retraction of the posterior leg muscles consists of a shortening of the muscle fibers that limits ankle dorsiflexion. The objective of this randomized controlled clinical trial (RCT) with a double-blind technique and longitudinal chronology is to evaluate the short-term effect of electrostimulation associated with muscle stretching (electrical muscle elongation technique or EME) compared to static stretching in adult subjects with shortening of the posterior leg muscles. The main questions it seeks to answer are:

  • Are there significant differences in the short-term effect of electrical muscle elongation versus static stretching exercises on the gastrocnemius complex and Achilles tendon in young adults?
  • Does the ankle\'s range of motion increase in both weight-bearing and non-weight-bearing positions?
  • Does muscle strength increase in ankle plantar flexion? The researchers will compare the group receiving electrical muscle elongation with interferential current to the group receiving passive static stretching to assess whether there are significant differences in the effects on the ankle\'s range of motion and the muscle strength of the posterior leg muscles. Participants in this study will perform the following tasks:
  • Receive a session of electrical muscle elongation with TENS and static stretching performed by the researcher.
  • Follow the instructions during the intervention.
  • Undergo evaluations of ankle range of motion and plantar flexor muscle strength
  • Record their level of satisfaction after the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

September 23, 2024

Last Update Submit

December 12, 2025

Conditions

Keywords

Achilles tendongastrocnemius muscleelectric stimulationstatic stretchingarticular Range of Motionrandomized Clinical trialLongitudinalmuscle shorteningSession durationComparision groupElectric muscle elongationtriceps surae

Outcome Measures

Primary Outcomes (2)

  • Evaluation of the ankle range motion

    Assessment will be conducted in a prone position using a two-arm goniometer with the knee flexed and extended, as well as in a standing position with a digital inclinometer with the knee flexed and extended. Additionally, the distance from the big toe to the wall will be measured with a tape measure. This evaluation is carried , before and after a electric stimulation to compare if this measure may be different after this intervention At the beginning, during the intervention and a week later.

    Through study completion, an average of 2 weeks.

  • leg muscular force

    Assessment will be conducted with the subject in a supine position and with knees extended. The plantarflexor strength of the ankle will be measured using a portable dynamometer. Three measurements will be taken, and the average will be calculated. this measure is carried on to evaluation if the force of the posterior leg muscles may be increased At the beginning, during the intervention and a week later.

    Through study completion, an average of 2 weeks.

Secondary Outcomes (1)

  • Patient Global Impression of Improvement cuestionarie

    At the end of the study, an average of 2 weeks

Study Arms (2)

Experimental: static stretching

EXPERIMENTAL

Passive static stretching of the posterior leg muscles. Single session of 30 seconds per 4 sets with 30 seconds of rest

Other: Static stretching

Experimental: EME

EXPERIMENTAL

Electrical muscle elongation with interferential current. Dosage: 4kHz frequency and 100Hz frequency modulation amplitude. Self-adhesive surface electrodes (50x90 mm) and SONOPULS-492 equipment. Single session of 30 seconds per 4 sets with 30 seconds of rest.

Device: Electrical muscle elongation

Interventions

A passive static stretch of the posterior leg muscles will be performed with the subject in a supine position and knees extended, starting with the ankle at 90º and continuing until reaching the maximum tolerated dorsiflexion.

Experimental: static stretching

The intervention will be performed with the subject in a supine position with knees extended. Electrodes will be placed on the gastrocnemius muscles of the leg being assessed. The parameters will be selected. Static stretching will begin until resistance is felt, at which point the intensity of the electrical current will be increased to induce a visible and tolerable contraction. Simultaneously, the subject will be asked to perform an isometric contraction of the antagonist muscles, resisted by the investigator. When the subject feels the stretch again, the intensity of the current will be increased once more until a new movement barrier is reached.

Experimental: EME

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects affiliated with or related to the University of Seville.
  • Those with muscular shortening of the posterior chain of the limb.

You may not qualify if:

  • Subjects who engage in sports activity above the average of the sample or who follow an organized stretching program for the posterior leg muscles.
  • Hyperlaxity
  • History of musculoskeletal, neuromuscular injuries, joint disease, surgery on the lower leg, or serious illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Área Clínica de Podología

Seville, 41008, Spain

Location

Related Publications (4)

  • Mizuno T. Combined Effects of Static Stretching and Electrical Stimulation on Joint Range of Motion and Muscle Strength. J Strength Cond Res. 2019 Oct;33(10):2694-2703. doi: 10.1519/JSC.0000000000002260.

  • Espejo-Antunez L, Lopez-Minarro PA, Garrido-Ardila EM, Castillo-Lozano R, Dominguez-Vera P, Maya-Martin J, Albornoz-Cabello M. A comparison of acute effects between Kinesio tape and electrical muscle elongation in hamstring extensibility. J Back Musculoskelet Rehabil. 2015;28(1):93-100. doi: 10.3233/BMR-140496.

  • Espejo-Antúnez L, López-Miñarro PA, Albornoz-Cabello M, Garrido-Ardila EM. Acute effect of electrical muscle elongation and static stretching in hamstring muscle extensibility. Science & Sports. 1 de febrero de 2016;31(1):e1-7.

    RESULT
  • Espejo Antúnez L, Maya Martín J, Cardero Durán MA, Albornoz Cabello M. Aumento de la extensibilidad isquiotibial tras aplicar elongación muscular eléctrica. Fisioterapia. 1 de mayo de 2012;34(3):112-7.

    RESULT

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aurora Castro PhD

    University of Seville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This was a single-blind study. The Participants were blinded to the specific intervention they received, as both the Electrical Muscle Elongation (EME) technique and the Static Stretching (SS) technique involved similar positioning and physical manipulation of the ankle, making it challenging for them to distinguish the exact treatment modality. However, the Investigator (A.C-M, responsible for allocation and data recording) and the Care Provider (L.R-F, the podiatrist who applied the corresponding technique) were not blinded to the group assignment due to the distinct nature of the two interventions (one involving electrotherapy equipment and the other not).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the Experimental Group (Electrical Muscle Elongation, EME) or the Control Group (Static Stretching, SS) to compare the immediate and short-term effects of the interventions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator. Aurora Castro-Méndez.

Study Record Dates

First Submitted

September 23, 2024

First Posted

October 4, 2024

Study Start

June 1, 2024

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations